Linking ClinicalTrials.gov and PubMed to Track Results of Interventional Human Clinical Trials

Abstract

ObjectiveIn an effort to understand how results of human clinical trials are made public, we analyze a large set of clinical trials registered at ClinicalTrials.gov, the world’s largest clinical trial registry.Materials and MethodsWe considered two trial result artifacts: (1) existence of a trial result journal article that is formally linked to a registered trial or (2) the deposition of a trial’s basic summary results within the registry.ResultsThe study sample consisted of 8907 completed, interventional, phase 2-or-higher clinical trials that were completed in 2006-2009. The majority of trials (72.2%) had no structured trial-article link present. A total of 2367 trials (26.6%) deposited basic summary results within the registry. Of those , 969 trials (10.9%) were classified as trials with extended results and 1398 trials (15.7%) were classified as trials with only required basic results. The majority of the trials (54.8%) had no evidence of results, based on either linked result articles or basic summary results (silent trials), while a minimal number (9.2%) report results through both registry deposition and publication.DiscussionOur study analyzes the body of linked knowledge around clinical trials (which we refer to as the “trialome”). Our results show that most trials do not report results and, for those that do, there is minimal overlap in the types of reporting. We identify several mechanisms by which the linkages between trials and their published results can be increased.ConclusionOur study shows that even when combining publications and registry results, and despite availability of several information channels, trial sponsors do not sufficiently meet the mandate to inform the public either via a linked result publication or basic results submission.

Peering into the “rabbit hole” of publication bias and inadequate research transparency: Adding tangibility to the abstract

“…[67][68][69][70][71][72] Similarly, ClinicalTrials.gov and the reporting mandate in Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA of 2007) have also failed, and the changes proposed in late 2014 by the National Institutes of Health (NIH) and the Department of Health and Human Services (HHS) unfortunately do not provide any material assurance of rectifying these issues. [73][74][75][76][77][78][79][80][81][82][83][84][85][86] On the surface, the changes are desirable, as they call for an expansion in what exactly must be reported. Notably, however, the changes do nothing to address clinical trials that occurred before the FDAAA of 2007 initially went into effect; the changes are still reliant on the FDAAA of 2007, which has quite simply never been enforced; the changes would actually expand the responsibilities for enforcement even though there was a complete failure to enforce the FDAAA of 2007 in its original form; and the changes do not provide any explanation for the non-enforcement issue or any assurance of enforcement going forward.…”

“…Notably, however, the changes do nothing to address clinical trials that occurred before the FDAAA of 2007 initially went into effect; the changes are still reliant on the FDAAA of 2007, which has quite simply never been enforced; the changes would actually expand the responsibilities for enforcement even though there was a complete failure to enforce the FDAAA of 2007 in its original form; and the changes do not provide any explanation for the non-enforcement issue or any assurance of enforcement going forward. [73][74][75][76][77][78][79][80][81][82][83][84][85][86] On the other hand, the AllTrials initiative (www.alltrials.net) -a joint initiative of (in alphabetic order): Bad Science, The BMJ, the Centre for Evidence-based Medicine, the Cochrane Collaboration, the James Lind Initiative, PLoS, and Sense About Science -has gained much momentum since its launch in 2013, and it continues to fight in this arena. [87][88][89] It is being led in the U.S. by Dartmouth's Geisel School of Medicine and the Dartmouth Institute for Health Policy and Clinical Practice, with the official launch in the U.S. occurring just this year in late July.…”

Peering into the “rabbit hole” of publication bias and inadequate research transparency: Adding tangibility to the abstract

“…[67][68][69][70][71][72] Similarly, ClinicalTrials.gov and the reporting mandate in Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA of 2007) have also failed, and the changes proposed in late 2014 by the National Institutes of Health (NIH) and the Department of Health and Human Services (HHS) unfortunately do not provide any material assurance of rectifying these issues. [73][74][75][76][77][78][79][80][81][82][83][84][85][86] On the surface, the changes are desirable, as they call for an expansion in what exactly must be reported. Notably, however, the changes do nothing to address clinical trials that occurred before the FDAAA of 2007 initially went into effect; the changes are still reliant on the FDAAA of 2007, which has quite simply never been enforced; the changes would actually expand the responsibilities for enforcement even though there was a complete failure to enforce the FDAAA of 2007 in its original form; and the changes do not provide any explanation for the non-enforcement issue or any assurance of enforcement going forward.…”

“…Notably, however, the changes do nothing to address clinical trials that occurred before the FDAAA of 2007 initially went into effect; the changes are still reliant on the FDAAA of 2007, which has quite simply never been enforced; the changes would actually expand the responsibilities for enforcement even though there was a complete failure to enforce the FDAAA of 2007 in its original form; and the changes do not provide any explanation for the non-enforcement issue or any assurance of enforcement going forward. [73][74][75][76][77][78][79][80][81][82][83][84][85][86] On the other hand, the AllTrials initiative (www.alltrials.net) -a joint initiative of (in alphabetic order): Bad Science, The BMJ, the Centre for Evidence-based Medicine, the Cochrane Collaboration, the James Lind Initiative, PLoS, and Sense About Science -has gained much momentum since its launch in 2013, and it continues to fight in this arena. [87][88][89] It is being led in the U.S. by Dartmouth's Geisel School of Medicine and the Dartmouth Institute for Health Policy and Clinical Practice, with the official launch in the U.S. occurring just this year in late July.…”

Interactive Visual Displays for Interpreting the Results of Clinical Trials: Formative Evaluation With Case Vignettes (Preprint)

“…National clinical trial registries such as ClinicalTrials.gov have taken an important step towards the implementation of structured reporting. However, several challenges still exist such as automatically extracting key study data from clinical trial registries [59]; incomplete linkage between clinical trial publications and clinical trial registration [60]; time delay between clinical trial publication and reporting of results in clinical trial registries [59]. Increasing requirements for structured reporting of clinical trials could be a possible solution.…”